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Nutritional Interventions in Chronic Heart Failure

2021년 1월 31일 업데이트: National Taiwan University Hospital

The Effect of Using Nutrition Education as an Intervention Measure on Elevating the Nutritional Status, Quality of Life, and Self-Care Behavior of Patients With Chronic Heart Failure

This study recruited patients diagnosed with heart failure by cardiologists and cardiac outpatients whose cardiac functions were graded from 1 to 4 according to the New York Heart Association as the study participants. The participants were provided active nutrition intervention including diet optimization,specific recommendations and nutritional supplement prescriptions in cases in which nutritional goals were not reached.In addition, this study offered advice by referencing lifestyle change advice provided by the American Heart Association for patients with heart failure.

The Mini Nutritional Assessment Short-Form was used to assess malnutrition indicator values. The participant water, nutrient (i.e., carbohydrates, protein, and fat), and calorie intake data were collected using their recollection of their dietary intake and food intake frequency over a 24-hour dietary recall. The amount of fluid and sodium administered was provided according to the cardiac function grades indicated by the New York Heart Association.In addition, dietary assessments and nutritional advice were offered on the basis of the patients' conditions (i.e., age, activity, and comorbidity).

Finally, instrumental activities of daily living, EQ-5D (an instrument for measuring quality of life), grip performance, and 6-minute walk test data were utilized to analyze the changes in the participants before and after intervention, identifying the correlation between using nutrition education as an intervention measure and improvement in the participants' nutritional status, quality of life, and self-care behavior.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Malnutrition may be caused by decreased nutrient intake or absorption, inflammation, or other disease-related mechanisms. Malnutrition resulting from disease or injury may be caused by decreased food intake or varying degrees of acute or chronic inflammation, which alters body composit ion and prompts a decline in biological functions. The effects of decreased food intake induced by an inflammatory reaction are related to the malnourishment resulted from anorexia, changes in metabolism, increased resting energy expenditure, and increased muscle catabolism. Changes in body composition are characterized by a decrease in any muscle mass marker (excluding fat mass, muscle mass index, or body cell mass). Therefore, malnutrition is associated with clinical results of clinical malfunction.

The primary objectives of heart failure treatment include preventing the need for hospitalization, increasing the survival rate, and improving health status. Patient symptoms, bodily functions, and health status are also referred to as health-related quality of life (HRQoL). The EuroQol-5D (EQ-5D) is used to assess the quality of life of patients undergoing cardiac rehabilitation. This assessment uses 5 aspects, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, to assess patient health status.

Cardiopulmonary exercise testing (CPET) is the gold standard method for evaluating the motor ability of patients with chronic heart failure (CHF), yet is not extensively used. A more commonly used and simpler method is the 6-minute walk test, which measures the distance traveled by walking for 6 minutes. Changes in this value correlate to quality of life. This test is used to investigate the ability to perform daily activities and intensity of exercise in patients with mild to moderate CHF.

Muscle strength is a key indicator for assessing patients with sarcopenia because decreased muscle strength is considered a crucial element in diagnosing muscle reduction. For circumstances in which muscle mass is difficult to assess, muscle strength, such as handgrip strength, can serve as a standard assessment of muscle functions.

Exercise training is considered a valid method for stabilizing patients with heart failure. One study reported that the self-management intervention of a patient with heart failure notably decreased the occurrence of hospitalization and hospital readmission related to heart failure as well as all-cause mortality.

The present study determines the effectiveness of nutrition intervention in routine medical treatment for improving the nutrition and quality of care among patients with heart failure.

This study does not involve drugs, medical technology, or medical equipment.

연구 유형

중재적

등록 (실제)

95

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대만
    • Yunlin County
      • Douliu, Yunlin County, 대만, 640
        • Department of Internal Medicine, National Taiwan Univeristy Hospital Yun-Lin branch

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Patients diagnosed with CHF by a cardiologist. Clinical patients with the functional classification of NYHA FcI-NYHA FcⅣ according to the New York Heart Association (NYHA).
  2. Adults aged 20 years or older who are conscious, have normal cognitive function, can walk without assistance, and do not require breathing aids. Additionally, participants must be able to answer questionnaires in Mandarin Chinese or Taiwanese, either orally or in writing.
  3. Patients who have agreed to participate in the study by completing a consent form.

Exclusion Criteria:

  1. Patients with an expected survival period of less than 6 months because of a disease not related to CHF
  2. Long-term bed-bound patients
  3. Patients with no potential for rehabilitation because of decline in functions of neural or musculoskeletal systems
  4. Patients with severe disorders of consciousness or cognitive disorders or those with mental illness
  5. Patients who require breathing aids for an extended period of time
  6. Patients with end-stage severe CHF who have been diagnosed by doctors as unable to recover within a short period
  7. Patients who are scheduled to undergo coronary artery bypass surgery or a heart valve surgery within 1 month
  8. Patients who are on hemodialysis or are awaiting a kidney transplant
  9. Patients with severe pulmonary diseases who require long-term home oxygen therapy
  10. Patients who themselves decline to participate or who have a family member who objects to their participation.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Nutritional intervention for CHF
행동: Self-Care Behavior
Limitations on liquid and sodium intake will be established in accordance with the NYHA functional classification, and patients will be provided with dietary assessments and nutrition advice according to personal characteristics such as age, physical activity level, and comorbidities. Additionally, suggestions on lifestyle changes were provided by referring to the advice for patients with heart failure from the American Heart Association.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mini Nutritional Assessment Short-Form
기간: Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).

Assess malnutrition indicator values. Nutrition status evaluated by the MNA correlates with energy and nutrient intakes as well as anthropometrics, hematologic, and biological nutrition parameters.

MNA has 4 sections: anthropometrics (BMI, weight loss, arm and calf circumference), general assessment (lifestyle, medication, mobility, presence of depression or dementia), dietary assessment (number of meals, food and fluid intake, autonomy of feeding), and subjective assessment (self-perception of health and nutrition).

The maximum score for the MNA-SF is 14, with scores ≥12 indicating satisfactory nutrition status and ≤11 indicating a risk of malnutrition.
Change from Baseline Mini Nutritional Assessment Short-Form on months 0, 3 at 6 months(Do higher values represent a better outcome).
Instrumental Activities of Daily Living
기간: Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.

Instrumental Activities of Daily Living Heath-related quality of life. IADL Scale was developed to assess more complex activities (termed "instrumental activities of daily living") necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic "activities of daily living" (e.g., eating, bathing, toileting) which are measured by ADL scales. Therefore, assessing IADLS may identify incipient decline in older adults or other individuals who are otherwise capable and healthy.

It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning).

This scale can be administered through an interview or by a written questionnaire.
Change from Baseline Instrumental Activities of Daily Living on months 0, 3 at 6 months.
EuroQol-5D
기간: Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).

Assess the quality of life of patients undergoing cardiac rehabilitation. the generic EuroQol fivedimensional questionnaire (EQ-5D) instrument are commonly referred to as value sets; an important distinction lies in whether the valuations are elicited from individuals with experience of the health state (experience-based values) or from individuals from the general population to whom the health states are described (hypothetical values).

  • 100 means the best health you can imagine.
  • 0 means the worst health you can imagine.
Change from Baseline EuroQol-5D on months 0, 3 at 6 months(Do higher values represent a better outcome).
Handgrip strength
기간: Change from Baseline Handgrip strength on months 0, 3 at 6 months.
Assessment of muscle functions. Measured by dynamometer, before and after intervention. We will compare the statistical properties of between baseline and after 0, 3 at 6 months intervention.
Change from Baseline Handgrip strength on months 0, 3 at 6 months.
6-Minute walk test
기간: Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).
Changes in this value correlate to quality of life
Change from Baseline 6-Minute walk test on months 0, 3 at 6 months(Do higher values represent a better outcome).

2차 결과 측정

결과 측정
측정값 설명
기간
Energy intake
기간: Change from Baseline Energy intake on months 0, 3 at 6 months.
Energy intake (Kcal/day)will be assessed by dietary survey on 24-hour recall.
Change from Baseline Energy intake on months 0, 3 at 6 months.
Carbohydrate intake
기간: Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.
Carbohydrate intake (g / day) will be assessed by dietary survey on 24-hour recall.
Change from Baseline Carbohydrate intake on months 0, 3 at 6 months.
Protein intake
기간: Change from Baseline Protein intake on months 0, 3 at 6 months.
Protein intake (g / day) will be assessed by dietary survey on 24-hour recall.
Change from Baseline Protein intake on months 0, 3 at 6 months.
Fat intake
기간: Change from Baseline Fat intake on months 0, 3 at 6 months.
Fat intake (g / day) will be assessed by dietary survey on 24-hour recall.
Change from Baseline Fat intake on months 0, 3 at 6 months.
Sodium intake
기간: Change from Baseline Sodium intake on months 0, 3 at 6 months.
Sodium intake (gm / day) will be evaluated by dietary survey on 24-hour recall.
Change from Baseline Sodium intake on months 0, 3 at 6 months.
Water intake
기간: Change from Baseline Water intake on months 0, 3 at 6 months.
Water intake (ml / day) will be evaluated by dietary survey on 24-hour recall.
Change from Baseline Water intake on months 0, 3 at 6 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Taiwan University Hospital

수사관

  • 수석 연구원: Jien-Jiun Chen, MD, National Taiwan University Hospital Yunlin Branch
  • 수석 연구원: Feng-Ching Liao, BS, National Taiwan University Hospital Yunlin Branch
  • 수석 연구원: Sheng Nan Chang, PhD, National Taiwan University Hospital Yunlin Branch
  • 수석 연구원: Shao-Chi Yang, MD, National Taiwan University Hospital Yunlin Branch
  • 수석 연구원: Chih-Neng Hsu, MD, National Taiwan University Hospital Yunlin Branch

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 19일

기본 완료 (실제)

2020년 12월 13일

연구 완료 (실제)

2020년 12월 13일

연구 등록 날짜

최초 제출

2019년 1월 8일

QC 기준을 충족하는 최초 제출

2019년 2월 17일

처음 게시됨 (실제)

2019년 2월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 1월 31일

마지막으로 확인됨

2020년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 201810039RINA

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

De-identified individual participant data for all primary and secondary outcome meaurses will be made available

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 심부전에 대한 임상 시험

Self-Care Behavior에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Zambia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다